PMID- 35688490
OWN - NLM
STAT- MEDLINE
DCOM- 20220614
LR  - 20220728
IS  - 1873-4111 (Electronic)
IS  - 0378-5122 (Linking)
VI  - 161
DP  - 2022 Jul
TI  - Impact of micronised progesterone and medroxyprogesterone acetate in combination 
      with transdermal oestradiol on cardiovascular markers in women diagnosed with 
      premature ovarian insufficiency or an early menopause: a randomised pilot trial.
PG  - 18-26
LID - S0378-5122(22)00025-1 [pii]
LID - 10.1016/j.maturitas.2022.01.012 [doi]
AB  - OBJECTIVE: To compare the difference between micronised progesterone (MP) and 
      medroxyprogesterone acetate (MPA) in combination with transdermal oestradiol 
      (t-E(2)) on cardiovascular disease (CVD) risk markers in women diagnosed with an 
      early menopause and premature ovarian insufficiency (EMPOI). BACKGROUND: The 
      European Society for Cardiology has identified carotid femoral pulse wave 
      velocity (cfPWV) as the gold standard cardiogenic biomarker for risk 
      stratification of arterial disease. Menopause has been shown to augment the 
      age-dependent increase in arterial stiffness, with hormone replacement therapy 
      (HRT) being the mainstay of management of women diagnosed with EMPOI. STUDY 
      DESIGN: A pilot randomised prospective open-label trial. Women were randomised to 
      either cyclical MP (Utrogestan(R) 200mg) or MPA (Provera(R) 10mg) in conjunction with 
      t-E(2) (Evorel(R) Patches 50mcg/day) for 12 months. Seventy-one subjects were 
      screened, and baseline data are available for 57 subjects. MAIN OUTCOME MEASURE: 
      Carotid-femoral pulse wave velocity (cfPWV). RESULTS: PWV did not significantly 
      change from baseline in either treatment arm. MP + t-E(2) demonstrated a positive 
      effect on traditional CVD markers, with a significant improvement seen in cardiac 
      output (CO) (0.71+/-1.01mL/min, 95% CI 0.20 to 1.21) and reduction in diastolic 
      blood pressure (DBP) (-3.43+/-6.31mmHg, 95% Cl -6.57 to -0.29) and total peripheral 
      resistance (TPR) (-0.15+/-0.19mmHg⋅min⋅mL(-1), 95% CI -0.24 to -0.05) after 12 
      months. MPA + t-E(2), in contrast, did not demonstrate significant changes from 
      baseline in traditional haemodynamic parameters. CONCLUSION: The positive changes 
      in traditional markers were not reflected in the cardiogenic biomarker, cfPWV, 
      which has demonstrated a higher positive predictive value for cardiovascular 
      events than traditional measurements.
CI  - Crown Copyright (c) 2022. Published by Elsevier B.V. All rights reserved.
FAU - Mittal, Monica
AU  - Mittal M
AD  - Imperial College Healthcare NHS Trust, St Mary's and Hammersmith Hospitals, 
      Department of Obstetrics and Gynaecology, Praed Street, London W2 1NY. Electronic 
      address: monica.mittal@nhs.net.
FAU - McEniery, Carmel
AU  - McEniery C
AD  - University of Cambridge, Division of Cardiovascular Medicine, Addenbrooke's 
      Hospital, Cambridge, Hills Road, Cambridge CB2 0QQ.
FAU - Supramaniam, Prasanna Raj
AU  - Supramaniam PR
AD  - Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, 
      Department of Obstetrics and Gynaecology, Headley Way, Headington, Oxford OX3 
      9DU.
FAU - Cardozo, Linda
AU  - Cardozo L
AD  - King's College Hospital NHS Foundation Trust, Department of Obstetrics and 
      Gynaecology, Denmark Hill, Brixton, London SE5 9RS.
FAU - Savvas, Mike
AU  - Savvas M
AD  - King's College Hospital NHS Foundation Trust, Department of Obstetrics and 
      Gynaecology, Denmark Hill, Brixton, London SE5 9RS.
FAU - Panay, Nick
AU  - Panay N
AD  - Imperial College Healthcare NHS Trust and Chelsea and Westminster NHS Foundation 
      Trust, Queen Charlotte's and Chelsea Hospital, Department of Obstetrics and 
      Gynaecology, Du Cane Rd, White City, London W12 0HS.
FAU - Hamoda, Haitham
AU  - Hamoda H
AD  - King's College Hospital NHS Foundation Trust, Department of Obstetrics and 
      Gynaecology, Denmark Hill, Brixton, London SE5 9RS.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20220202
PL  - Ireland
TA  - Maturitas
JT  - Maturitas
JID - 7807333
RN  - 0 (Biomarkers)
RN  - 4G7DS2Q64Y (Progesterone)
RN  - 4TI98Z838E (Estradiol)
RN  - C2QI4IOI2G (Medroxyprogesterone Acetate)
SB  - IM
MH  - Biomarkers
MH  - *Cardiovascular Diseases/prevention & control
MH  - Estradiol
MH  - Female
MH  - Humans
MH  - Medroxyprogesterone Acetate/pharmacology/therapeutic use
MH  - Menopause
MH  - *Menopause, Premature
MH  - Pilot Projects
MH  - *Primary Ovarian Insufficiency/drug therapy
MH  - Progesterone/therapeutic use
MH  - Prospective Studies
MH  - Pulse Wave Analysis
OTO - NOTNLM
OT  - Medroxyprogesterone acetate
OT  - carotid femoral pulse wave velocity (cfPWV)
OT  - hormone replacement therapy (HRT)
OT  - micronised progesterone
OT  - progesterone
OT  - transdermal oestrogen
COIS- The authors declare that they have no competing interests.
EDAT- 2022/06/11 06:00
MHDA- 2022/06/15 06:00
CRDT- 2022/06/10 21:04
PHST- 2021/09/16 00:00 [received]
PHST- 2022/01/15 00:00 [revised]
PHST- 2022/01/19 00:00 [accepted]
PHST- 2022/06/10 21:04 [entrez]
PHST- 2022/06/11 06:00 [pubmed]
PHST- 2022/06/15 06:00 [medline]
AID - S0378-5122(22)00025-1 [pii]
AID - 10.1016/j.maturitas.2022.01.012 [doi]
PST - ppublish
SO  - Maturitas. 2022 Jul;161:18-26. doi: 10.1016/j.maturitas.2022.01.012. Epub 2022 
      Feb 2.